A federal Senate Inquiry is now gathering evidence on transvaginal mesh implants, which Senator Derryn Hinch has described as "one of the greatest medical scandals and abuses of mothers in Australia?s history".

May 10th 2017

2 years ago

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Retired teacher Jan Hawkins is one of hundreds of Australian women who claim they were butchered by a mesh implant manufactured by Johnson & Johnson.Source:Supplied

WARNING: Graphic content.

A CONSULTANT who raised concerns about a controversial surgical mesh accused of butchering hundreds of Australian women told the manufacturers: “I would not like my wife to undergo this procedure ... not in my wife”, a court has heard.

Shine’s class action barrister Tony Bannon, SC, read the excerpt from an email that was allegedly sent by Total Transvaginal Mesh (TVM) French consultant Bernard Jacquetin to Johnson & Johnson personnel. Dr Bernard was enlisted to conduct clinical trials for the implants. Mr Bannon said there was “no feedback” but that the doctor was now earning royalties from their use.

“That is one of the transvaginal mesh team members, one of the consultants. His view is that ‘I wouldn’t like my wife to undergo that, and I don’t think I’m alone’,” Mr Bannon said.

Hundreds of Australian women who allege pelvic mesh implants have left them with catastrophic injuries to their internal organs have today taken the manufacturers to court for damages.

More than 700 women have joined the class action against Johnson & Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl to seek hundreds of millions in compensation, as the case gets underway in Sydney’s Federal Court today.

They claim the surgical mesh approved by Australia’s medicine watchdog has disfigured and disabled them, caused chronic pain and destroyed their sex lives.

It will also be alleged that the implants were not fit for their purpose, were not of merchantable quality, were not safe and that the companies were negligent for rushing the devices onto the market without clinical testing. Instead, the mesh was “aggressively market(ed)” to surgeons as a cheap and easy way to boost their profits, the court heard.

The controversial mesh implants have been used to treat urogynaecological issues typically caused by child birth in thousands of Australian women since 2000.

Medical reviews claim up to one in eight suffer complications including scarring, infection, bleeding, organ perforation, incontinence and recurrent prolapse. Several patients claim the mesh has eroded their organs and fused others together.

Primary school teacher Jan Hawkins, 60, said she was forced to retire after she developed severe complications from a pelvic mesh implant she had inserted in 2007.

“It’s like sandpaper inside you that every now and then rears its ugly head and pokes through organs and walls, which affects nerves and how they function,” Ms Hawkins told news.com.au.

“It’s a terrible thing that rubs and creates a cheese grater effect.”

Ms Hawkins, from Terrigal on the NSW Central Coast, said she felt discomfort immediately following the surgical procedure and was soon “filled with horror”.

“I had some ghastly tests that showed the mesh had buckled and folded,” she said.

“Everything had prolapsed and I had terrible troubles with the bowel.

“Everything was in a real mess and ulcers had started forming.”

Jan Hawkins is one of hundreds of women involved in a class action against medical giant Johnson & Johnson.Source:Supplied

Hundreds of Australian women claim mesh implants like this ‘Total Vaginal Mesh’ device “butchered” them. In this picture, areas 1 and 2 “cover the posterior and anterior vaginal walls”. The front section is held in place by two arms, and the back section by one arm.Source:Supplied

With full medical cover and “all of the extras” it still cost her a total of about $20,000 to have one of only about two doctors in Australia who can remove the implants carry out the procedure in 2013.

“The doctor that removed the mesh said it was about the size of an iPhone screen and that he had to remove the whole back wall of the vagina,” Ms Hawkins said.

“I was black and blue down to my knees ... there was blood transfused ... it was big.”

It couldn’t be completely removed so parts of the mesh and its hooks remain inside the mother-of-three’s body, continuing to cause her pain and other medical complications.

“I lived on pain killers for a while because of ongoing leg problems where I can’t stand for long as a result of aching that is quite severe,” she said.

“I feel so reconstructed, sometimes you don’t feel like you can function on a normal level, and daily functions aren’t normal.”

But Ms Hawkins said she was “one of the lucky ones”. In most cases, the mesh can’t be removed.

“It’s designed to hook into the tissues so they grow in and around it so getting rid of it is often impossible,” she said.

Shine class action lawyer Rebecca Jancauskas told news.com.au that the pelvic mesh implants had changed the lives of many Australian women forever.

“The complications that Australian women are suffering include the mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain,” Ms Jancauskas said.

“Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives.

“In many cases they are even unable to be intimate with their partners. It has had truly devastating consequences.”

She estimated that up to 10,000 women could be affected by complications.

None of the products have been recalled and some remain on the market today, according to Ms Jancauskas.

“This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives,” she said.

“They can’t just make products and put them in women, destroy their lives and say ‘I can do that’ — and that’s what they’ve done.

“(Johnson & Johnson need to be held) accountable and responsible.”

Fellow claimant Jo Mannion told reporters she hoped the case would bring her some closure after years of pain.

The landmark class action is one of the largest medical civil cases in Australia. The action could dwarf the $250 million settlement Johnson & Johnson paid out last year over its DePuy hip implant that left hundreds of patients poisoned and seriously disabled. It has been set down for six months.

A Johnson & Johnson spokesperson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide.

“These pelvic mesh products have been developed in close consultation with specialist surgeons and are backed by years of clinical research,” a statement from the company read. “We have always complied fully with local regulatory requirements when providing the products in Australia, and have acted ethically and responsibly in the research, development and supply of the products.”

This pelvic mesh had “glued up” the glide plane that normally allows the bladder to slide without friction across the anterior vaginal wall. Scar tissue had contracted the mesh, creating vaginal deformity and chronic pain in an anonymous patient.Source:Supplied

Earlier this year, Senator Derryn Hinch described it as “the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs”.

“It has to be halted until it is proven safe because there are too many cases where this is crippling people for life,” Mr Hinch said in February.

A Senate inquiry into transvaginal mesh devices will hear from women across the country who were left with injuries.

Another 300 Australian women are registered for a second class action against American Medical Systems, which developed mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, and relied on the Australian-developed device for clearance. News.com.au understands other Australian women have filed lawsuits against individual doctors.

Australia’s Therapeutic Goods Administration still allows surgeons to implant the mesh despite bans, warnings and withdrawals in other countries and more than 120,000 pending lawsuits in the US. However, some of the implants have been discontinued.